None listed
Conditions
Brief summary
The purpose of the study is to investigate the intra-articular injection of growth hormone in combination with a carrier for arthritis in the knee and ankle. The hypothesis of the study is the intra-articular injection of growth hormone will increase healing of arthritic or injured joints when compared to the saline placebo treatment. The patients are to be referred by their GP to be recruited to the private surgical clinic. The pain and mobility of the joints will be measured by using the Foot and Ankle Outcome Score (FAOS) and the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index to test the mobility of the ankle and knee respectively.
Interventions
Intra-articular injection of growth hormone and platelet-rich plasma (PRP) within the knee and ankle. International Non-Proprietary name is somatropin, or recombinant human growth hormone. One dosage is a 10 IU intra-articular injection of somatropin and 10mL of PRP.
Total of 3 injections of somatropin and PRP conjunct. The patient will receive the injection on either ankle or knee joint, guided by an ultrasound to accurately get the joint. Injection of the somatropin and PRP will happen concur
Intra-articular injection of growth hormone and platelet-rich plasma (PRP) within the knee and ankle. International Non-Proprietary name is somatropin, or recombinant human growth hormone. One dosage is a 10 IU intra-articular injection of somatropin and 10mL of PRP. Total of 3 injections of somatropin and PRP conjunct. The patient will receive the injection on either ankle or knee joint, guided by an ultrasound to accurately get the joint. Injection of the somatropin and PRP will happen concurrently, with the injections spaced 7 to 16 days apart. This trial will occur within a private surgical clinic with the intervention administered by the Orthopaedic Surgeon. A session attendance checklist using a practice management software, Clinic to Cloud, will monitor the adherence to the intervention.
Intra-articular injection of recombinant human growth hormone (rhGH; somatropin) in combination with platelet-rich plasma (PRP) for the treatment of knee and ankle osteoarthritis. Each dose in the active treatment arm consists of 15 IU of somatropin administered in combination with 10 mL of autologous PRP. Participants will receive a total of five intra-articular injections into the affected knee or ankle joint, with injections administered 7–16 days apart. Injections will be performed under ult
Intra-articular injection of recombinant human growth hormone (rhGH; somatropin) in combination with platelet-rich plasma (PRP) for the treatment of knee and ankle osteoarthritis. Each dose in the active treatment arm consists of 15 IU of somatropin administered in combination with 10 mL of autologous PRP. Participants will receive a total of five intra-articular injections into the affected knee or ankle joint, with injections administered 7–16 days apart. Injections will be performed under ultrasound guidance by a qualified Orthopaedic Surgeon to ensure accurate intra-articular placement. Somatropin and PRP will be administered concurrently as a combined investigational treatment. Following each injection, participants will undergo 20 minutes of non-invasive joint distraction. The trial will be conducted at private clinical sites, with treatment prepared and administered by appropriately qualified clinical personnel. Treatment adherence will be monitored through clinical attendance and administration records maintained in a secure cloud storage database.
Sponsors
Integrant Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Ankle/Knee arthritis resistant to treatment in GP clinic setting. Significant Ankle/Knee cartilage injury can be shown on MRI scan or weight bearing X-Ray. Able to give informed consent to participation in a clinical trial. Able to commit to attending clinic for follow up.
Exclusion criteria
A known hypersensitivity to any of the components of the product. Cancer diagnosis or suspicion. Resected or active tumor. Skeletally immature ( 5% No cartilage detected in the joint (bone on bone in medical imaging) Unable to give informed consent. Unable to commit to attend clinic for follow up.
Outcome results
None listed